Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis

Scynexis, Inc.27 enrolled

Overview

The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.

Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mycoses Candidiasis, Invasive Candidemia

Interventions

SCY-078DRUG

FluconazoleDRUG

MicafunginDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for Candida. * Not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception. Exclusion Criteria: * Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis. * Patient has failed treatment with an echinocandin for this episode of invasive candidiasis. * Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture. * Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.

Locations (30)

Outcomes

Primary Outcomes

Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements

All Related TEAEs by SOC and PT, by Treatment, Safety

Time frame: up to 10 weeks

Dose of SCY-078 That Achieves the Target Exposure (AUC)

Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK

Time frame: 0 to 24 hours post-dose

Secondary Outcomes

Global Response

Participant's clinical response (signs or symptoms) and microbiological response (presence of Candida culture)

Time frame: end of all antifungal therapy (administered for a maximum of 28 days)

Clinical Response

Participant's persistence of signs or symptoms and administration of systemic non-study antifungal therapy

Time frame: end of all antifungal therapy (administered for a maximum of 28 days)

Microbiological Response

Cultures or radiographs/imaging of blood or non-blood sites of infection showing evidence of Candida infection

Time frame: end of all antifungal therapy (administered for a maximum of 28 days)

Relapse

If Invasive Candida infection recurs or if antifungal therapy for a proven or suspected Candida infection is administered

Time frame: 2 weeks and 6 weeks after the end of all antifungal therapy, up to 10 weeks

Data from ClinicalTrials.gov

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